Lisinopril is an orally active angiotensin-converting enzyme (ACE) inhibitor used primarily in the treatment of hypertension and heart failure. It is also used to reduce the risk of mortality and morbidity following acute myocardial infarction and for the management of certain diabetic kidney complications.
Lisinopril inhibits ACE, the enzyme responsible for converting angiotensin I to angiotensin II. Reduction of angiotensin II decreases vasoconstriction and aldosterone secretion, resulting in reduced blood pressure and decreased cardiac workload.
Lisinopril is a well-established cardiovascular pharmaceutical API used in the manufacture of oral solid dosage formulations. It is a synthetic peptide-like ACE inhibitor and is commonly supplied as lisinopril dihydrate.
Important API quality attributes include identity, assay, related substances, water content, specific optical rotation, residue on ignition and residual solvents.
CAS Number: 83915-83-7
Molecular Formula: C21H31N3O5·2H2O
Molecular Weight: 441.52 g/mol
Anhydrous Molecular Weight: 405.49 g/mol
Chemical Name: (2S)-1-[(2S)-6-amino-2-[[(1S)-1-carboxy-3-phenylpropyl]amino]hexanoyl]pyrrolidine-2-carboxylic acid dihydrate
Synonyms: Lisinopril Dihydrate, Lisinopril Hydrate
Drug Class: ACE Inhibitor
Therapeutic Class: Antihypertensive / Cardiovascular Agent
Therapeutic Area: Cardiovascular / Renal
Lisinopril competitively inhibits angiotensin-converting enzyme (ACE).
ACE inhibition results in:
Lisinopril also inhibits the breakdown of bradykinin, contributing to some of its pharmacological effects.
Lisinopril API is used in pharmaceutical formulations for:
Lisinopril Dihydrate is generally described as a white to off-white crystalline powder. It is soluble in water and has a highly polar, peptide-like chemical structure.
A controlled Lisinopril API manufacturing process may involve:
Typical Lisinopril API testing may include:
Store Lisinopril API in a tightly closed container under controlled pharmaceutical storage conditions, protected from excessive heat, moisture and direct light. Storage requirements should follow the manufacturer's validated stability data.
Lisinopril is relevant to research involving:
| Parameter | Specification |
|---|---|
| Appearance | White to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | 98.0% – 102.0% |
| Loss on Drying | NMT 2.0% |
| Residue on Ignition | NMT 0.2% |
| Heavy Metals | NMT 20 ppm |
| pH (1% Solution) | 5.0 – 7.0 |
| Water Content | 8.0% – 10.0% |